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RegisterProtocol for enteric coated orally dispersible tablets [Design Issues]
Hi all,
Can any body say is there any specific issues in designing a protocol for delayed release orally dispersible drug?
• Is there any point to be borne in mind while designing the BE protocol?
• Is single dose replicate fasting study essential?
• How will you manage if the drug is highly variable – if it exhibits non linear PK
• Can multi-dose studies be conducted?
Thanks in advance & best regards
pharmwhiz
Can any body say is there any specific issues in designing a protocol for delayed release orally dispersible drug?
• Is there any point to be borne in mind while designing the BE protocol?
• Is single dose replicate fasting study essential?
• How will you manage if the drug is highly variable – if it exhibits non linear PK
• Can multi-dose studies be conducted?
Thanks in advance & best regards
pharmwhiz
Complete thread:
- Protocol for enteric coated orally dispersible tabletspharmwhiz 2007-09-19 14:02
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Protocol for enteric coated orally dispersible tablets chirayu 2007-10-09 07:53
- Strange formulation... Helmut 2007-10-09 15:10
- Protocol for enteric coated orally dispersible tablets chirayu 2007-10-09 07:53
Ing. Helmut Schütz